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Objective To evaluate the safety and efficacy of intra-articular (IA) injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE® for knee osteoarthritis. Methods This was a patient-blind, randomized, active-control trial consisted of 4 arms including hyaluronic acid (HA) control and 3 ELIXCYTE® doses. A total of 64 subjects were screened, and 57 subjects were randomized. The primary endpoints included the changes from baseline to post-treatment visit of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at Week 24 and the incidence of adverse events (AEs) and serious adverse events (SAEs). Results No ELIXCYTE®-related serious adverse events were reported during 96 weeks of follow-up and no suspected unexpected serious adverse reaction (SUSAR) or death was reported. The changes of the primary endpoint, WOMAC pain score at Week 24, showed significant differences in all ELIXCYTE® groups, as well as in HA groups between post-treatment visit and baseline. The ELIXCYTE® groups revealed significant decreases at Week 4 compared to HA group in WOMAC total scores, stiffness scores, functional limitation scores suggested the potential of ELIXCYTE® in earlier onset compared to those from HA. The significant differences of visual analog scale (VAS) pain score and Knee Society Clinical Rating System (KSCRS) functional activities score at Week 48 after ELIXCYTE® administration suggested the potential of ELIXCYTE® in the longer duration of the effectiveness compared to HA group. Conclusions ELIXCYTE® for knee osteoarthritis treatment was effective, safe, and well-tolerated. The efficacy results were showed that ELIXCYTE® conferred the earlier onset of reductions in pain scores and improvements in functional scores than HA group. Trial registration : ClinicalTrials.gov Identifier: NCT02784964. Registered 16 May, 2016—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02784964

Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths. 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. ClinicalTrials.gov NCT01429402.

Upper lip scars are at risk of hypertrophy. Our center therefore uses microporous tape and silicone sheeting for postoperative scar care following cleft lip repair. However, some babies have previously ingested their silicone sheeting, which has the potential for respiratory compromise or gastrointestinal obstruction. Self-dry silicone gel is reportedly also effective for preventing hypertrophic scars. Hence, we sought to test whether silicone gel, which cannot be ingested whole, might be non-inferior to silicone sheeting for controlling against upper lip scar hypertrophy. This was a mixed prospective and retrospective case-controlled clinical trial involving patients undergoing unilateral cleft lip repair, 29 of whom received standard postoperative silicone sheeting (control group) and another 33 age-matched consecutive patients who received self-dry silicone instead. The Vancouver scar scale, visual analogue scale and photographically assessed scar width assessments were the same in both groups at six months after surgery. In conclusion, silicone gel appears to be non-inferior to silicone sheeting for postoperative care of upper lip scars as judged by scar quality at six months, but silicone sheeting has the safety disadvantage that it can be swallowed whole by babies. It is thus recommended that silicone gel be used for upper lip scar management in babies.

To evaluate efficacy and safety of picosecond 755 nm alexandrite laser as compared to 1064 nm QS-Nd:YAG laser for melasma treatment in Asians. Twelve patients received 4 sessions of treatments at 1-month interval in a split-face manner. The right side of each patient’s face received 755 nm picosecond laser, and the other side received 1064 nm QS-Nd:YAG laser. Zoom handpiece of 755 nm picosecond laser at fluence of 0.88–1.18 J/cm2 was applied. The treatment protocol used for 1064 nm QS-Nd:YAG laser was 8 mm spot size at fluence of 2.0 J/cm2 initially followed by 6 mm spot size at fluence of 3.5 J/cm2, and finishing with 4 mm spot size at 3.2 J/cm2. For both 755 nm picosecond laser and 1064 nm QS-Nd:YAG laser, the endpoint was mild erythema and swelling without petechiae. Objective evaluation with visual analogue score was conducted by two independent physicians. Subject self-assessment for each patient was conducted as well. Statistical results showed that higher pigmentation clearance rate was achieved at the 755 nm picosecond laser side after the second treatment. At the 3 months follow-up, greater clearance was observed at the 755 nm picosecond laser side compared to the 1064 nm QS-Nd:YAG side. 755 nm alexandrite picosecond laser has been observed to achieve a faster and better clearance rate for melasma compared to 1064 nm QS-Nd:YAG laser. We conclude that the 755 nm picosecond laser could be a safe and effective modality for melasma treatment in Asians.

The forehead flap is a dependable option for nasal reconstruction owing to its reliability and anatomic likeness to nasal skin. For patients with low hairlines, the vertical design of the paramedian forehead flap can intrude into the scalp, thus incorporating hair into the nasal reconstruction. The inadequate length of the forehead flap or shift to an oblique design may result in eyebrow elevation and asymmetry. Therefore, laser hair removal (epilation) on the forehead flap has been proposed to improve esthetic results. An alexandrite laser (755 nm, 10 to 20 ms, 18-mm spot size) with a Dynamic Cooling Device ™ (DCD ™ ) cooling system was used for hair removal in 22 patients (16 male and 6 female patients) after nasal reconstructions using forehead flaps from December 2011 to September 2016. All patients received cryogen spray cooling laser treatment (CSC-LT). The mean follow-up period was 24 months, with a range between 18 and 50 months. The average duration of treatment was 1.8 months (range, 1–5 months). The energy density ranged from 14 to 18 J/cm 2 with an average of 17.2 J/cm 2 . The number of treatments ranged from 2 to 4 (mean 2.8). Patients had satisfactory esthetic results over 11.1 months (range, 8–18 months). Residual white hairs were observed in 3 patients, and 4 patients had tiny black residual hairs without deteriorating cosmesis. Using an alexandrite laser to remove hair on the forehead is safe and reliable in nasal reconstruction with superior recipient site cosmesis.

Objectives Patients with cleft lip–cleft palate (CLP) often require orthodontic treatment, with or without orthognathic surgery. Patient satisfaction is the most important outcome parameter in orthodontic treatment. This study aimed to (1) determine patient satisfaction and quality of life (QoL) after orthodontic treatment and (2) identify associated factors. Material and methods This prospective cross-sectional study recruited patients with CLP who had completed orthodontic treatment at a craniofacial center in Taiwan. Participants ( N =213) had received treatment for unilateral CLP ( n =99), bilateral CLP ( n =50), cleft lip and alveolus ( n =39), and isolated cleft palate ( n =25). Self-report questionnaires evaluated satisfaction with appearance and QoL; multiple regression analysis examined associated factors. Participants’ expectations of treatment results were also reported. Results Participants reported moderate satisfaction with facial appearance and QoL. Satisfaction with treatment was lower or much lower than expected for 13% of participants. Treatment for bilateral CLP was associated with the lowest satisfaction with overall appearance ( r = −8.123, P < 0.05); participants who had received orthognathic surgery had the highest satisfaction ( r = 5.534, P < 0.05). Treatment for unilateral and bilateral CLP was associated with low QoL for smile (both P < 0.05). Conclusions Orthodontic treatment had a positive effect on facial appearance and quality of life in patients with CLP. Type of cleft and orthognathic surgery significantly influenced satisfaction with facial appearance. Clinical relevance Efforts must be taken to modify treatment strategies for patients with bilateral CLP in order to improve satisfaction with appearance following treatment.

Objectives To assess and compare the stability and outcomes of the two surgical approaches for patients with roll asymmetry. Materials and methods A total of 50 adult patients were consecutively recruited for this prospective study. Patients with class III asymmetry and lip or occlusal cant who underwent bimaxillary surgery were grouped according to surgical approach: asymmetric posterior impaction on both sides (API, n = 31) and posterior impaction on one side and posterior extrusion on the other side (PIE, n = 19). Postsurgical stability and outcomes between groups were determined with cone-beam computed tomography for facial midline, lip, and occlusal cant at 1 week (T1), and at least 12-month postsurgery (T2, completion of orthodontic treatment). Results Presurgery, the upper anterior occlusal cant and lip cant were significantly greater for the PIE group ( p < 0.05). Postsurgery (T2), the mandible moved upward and rotated upward in both groups. However, the upward rotation was significantly greater in the PIE group compared with the API group. Although the two approaches resulted in significant improvements in facial symmetry, the deviation in the facial midline remained under-corrected for most API patients. Conclusions Patient outcomes for mandibular stability and facial symmetry differed between the two surgical approaches for correction of class III asymmetry with lip or occlusal cant. Clinical relevance The findings of this study suggest that planned over-correction is a reasonable option for the approach of asymmetric posterior impaction on both sides.

The regeneration capacity of knee cartilage can be enhanced by applying periosteal grafts, but this effect varies depending on the different sources of the periosteal grafts applied for cartilage formation. Tibia periosteum can be used to enhance cartilage repair. However, long-term analysis has not been conducted. The endochondral ossification capacity of tibia periosteum during cartilage repair also needs to be investigated. In this study, both vascularized and non-vascularized tibia periosteum grafts were studied to understand the relationship between tissue perfusion of the periosteum graft and the effects on cartilage regeneration and bone formation. Furthermore, anti-ossification reagents were added to evaluate the efficacy of the prevention of bone formation along with cartilage regeneration. A critical-size cartilage defect (4 × 4 mm) was created and was covered with an autologous tibia vascularized periosteal flap or with a non-vascularized tibia periosteum patch on the knee in the rabbit model. A portion of the vascularized periosteum group was also treated with the anti-osteogenic reagents Fulvestrant and IL1β to inhibit unwanted bone formation. Our results indicated that the vascularized periosteum significantly enhanced cartilage regeneration in the cartilage defect region in long-term treatment compared to the non-vascularized group. Furthermore, the addition of anti-osteogenic reagents to the vascularized periosteum group suppressed bone formation but also reduced the cartilage regeneration rate. Our study using vascularized autologous tissue to repair cartilage defects of the knee may lead to the modification of current treatment in regard to osteoarthritis knee repair.

ObjectivesSome adults with cleft lip and palate (CLP) require orthognathic surgery due to skeletal deformity. This prospective study aimed to (1) compare skeletal stability following bimaxillary surgery for correction of class III deformity between patients with unilateral CLP (UCLP) and bilateral CLP (BCLP), and (2) identify risk factors of stability.Materials and methodsAdults with CLP and skeletal class III deformities who underwent surgery-first bimaxillary surgery were divided into two groups according to cleft type: UCLP (n = 30) and BCLP (n = 30). Skeletal stability was assessed with measures from cone beam computed tomography images of the maxilla and mandible taken before treatment, 1-week and ≥ 1 year postsurgery for translation (left/right, posterior/anterior, superior/inferior) and rotation (yaw, roll, pitch); multiple regression analysis examined risk factors.ResultsAt follow-up, the maxilla moved upwards in both groups, and backwards in the UCLP group. The mandible moved forward and upward, shifted to the cleft (deviated) side, and rotated upward in both groups. The amount of surgical advancement was a risk factor for sagittal stability in the maxilla (ß = −0.14, p < 0.05). The mandible had three risk factors for sagittal stability: age (ß = −0.23, p < 0.05), surgical team (ß = −1.83, p < 0.05), and amount of surgical setback (ß = −0.32, p = 0.001).ConclusionsTwo years after bimaxillary surgery, patients with UCLP had a higher sagittal relapse of the maxilla compared with patients with BCLP, which was due to a greater surgical advancement in the patients with UCLP.Clinical relevanceSurgery-first bimaxillary surgery results in favorable treatment outcomes for correction of cleft-related class III deformity. Severity of jaw discrepancy and surgeons should be considered in the surgical design of overcorrection.

Cleft lip and palate is the most common congenital craniofacial anomaly. Up to 60% of these patients will benefit from cleft orthognathic surgery, which consists primarily of maxillary advancement and mandibular setback to address midface retrusion and relative mandibular protrusion, respectively. It is believed that maxillary advancement can enlarge the airway whilst mandibular setback can reduce the airway, but this has not previously been quantified for cleft patients undergoing orthognathic surgery. This unique longitudinal prospective study of 18 patients was conducted between April 2013 and July 2016. No significant changes occurred by six months postoperatively in body mass index, apnoea-hypopnoea index or lowest oxygen saturation (LSAT). There was a mean increase of 0.73 cm 3 in velopharyngeal volume, a mean decrease of 0.79 cm 3 in oropharyngeal volume, an improvement in snoring index, and no statistically significant change in hypopharyngeal volume. In conclusion, cleft orthognathic surgery that produced anterior advancement of the maxilla, setback of the mandible and clockwise rotation of the maxillo-mandibular complex resulted in increased velopharyngeal, decreased oropharyngeal and unchanged hypopharyngeal airways, and improved snoring, but did not significantly alter objective sleep-related breathing function.